(42 days)
The Cervical Stand Alone System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Cervical Stand Alone System is used with autograft comprised of cancellous and/or corticocancellous bone graft and the two titanium alloy screws which accompany the implant.
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the Cervical Stand Alone System in the cervical spine.
Cervical Stand Alone system is designed to provide the biomechanical strength to a traditional or minimal invasive ACDF procedure with less disruption of patient anatomy and preserve the anatomical profile. The Cervical Stand Alone system helps to preserve the natural sagittal anatomic profile of the cervical spine while providing anterior column support and stability. Cervical Stand Alone is a hybrid PEEK (ASTM F-2026) and Titanium (Ti-6Al-4V) spacer which incorporates Titanium Bone Screws (Ti-6Al-4V) and a Titanium Cover Plate (Ti-6Al-4V). The Cervical Stand Alone spacers are designed with a zero anterior profile and are implanted using an anterior approach.
The provided document describes a medical device, the "Cervical Stand Alone System," and its premarket notification (510(k)) for FDA clearance. However, this document does not contain information about the acceptance criteria or a study proving the device meets the acceptance criteria in the context of an AI/ML medical device.
The document primarily focuses on:
- Regulatory Clearance: It's an FDA 510(k) clearance letter for a Class II medical device (intervertebral body fusion device).
- Device Description: Details about the Cervical Stand Alone System, its materials (PEEK, Titanium), and its intended use for spinal fusion in the cervical spine for patients with degenerative disc disease.
- Predicate Devices: It compares the device to previously cleared predicate devices (K142152 and K150619) to establish substantial equivalence.
- Performance Data (Non-Clinical): It mentions mechanical testing (Static and Dynamic Axial Compression Test, Static Torsion Test, Static Compression Shear Test, Subsidence Test, and Expulsion Test) conducted according to ASTM standards (F2077-14, F2267-04, and ASTM Draft Standard F-04.25.02.02).
There is no mention of:
- An AI/ML component.
- Acceptance criteria for AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
- A clinical study involving human readers or AI assistance.
- Ground truth establishment in the context of diagnostic performance.
- Training or test set sizes for an AI model.
Therefore, I cannot populate the requested table and answer the specific questions related to AI/ML device performance and testing. The document describes a traditional medical device's mechanical and material performance testing for regulatory clearance, not the performance of an AI-powered diagnostic or assistive tool.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.